Press Releases and Statements

In the first-in-human study BIOMAG-I, BIOTRONIK’s new-generation DREAMS 3G resorbable magnesium scaffold (RMS) showed significantly lower in-scaffold late lumen loss (LLL) than its predecessor at 12 months as well as excellent safety and efficacy. Prof. Michael Haude, BIOMAG-I Coordinating Clinical Investigator, presented the latest results in the late breaking trial session at the EuroPCR course. 1 At one-year follow-up, BIOMAG-I data confirmed the excellent safety profile of DREAMS 3G RMS with a low target lesion failure rate of 2.6%. Neither cardiac death and myocardial infarction occurred

BIOTRONIK, a leading global medical technology company with 60 years of experience in developing trusted cardiovascular and endovascular solutions, announced today the latest addition to its cardiac rhythm management portfolio. "We are excited to have received CE mark for our newest technology – the world’s first pacemakers and CRT-Ps approved for left bundle branch pacing. Amvia Sky and Amvia Edge represent cutting-edge innovation and incorporate the latest cardiology trends," says Dr. Andreas Hecker, President CRM/EP at BIOTRONIK. In 1963, BIOTRONIK introduced the first German implantable

The company today announced U.S. Food and Drug Administration (FDA) approval for Prospera™, a spinal cord stimulation (SCS) system. The system features RESONANCE™, the first and only multiphase stimulation paradigm, paired with Embrace One™, a patient-centric care model that makes proactive care possible by offering automatic, objective, daily remote monitoring and ongoing management and support. 1 This approval marks the launch of the company’s new business segment, BIOTRONIK Neuro. Millions of people all over the world suffer from chronic intractable pain, a severe, constant, and

Results from the MATRIX study show that the high detection accuracy of DX single-lead ICD systems for atrial fibrillation (AF) episodes (99.7% for ≥ 1h episodes) in combination with the strong transmission performance of BIOTRONIK Home Monitoring ® allows for reliable guideline-recommended remote monitoring of subclinical AF. The findings were published in Europace earlier this week. 1 MATRIX evaluated the utility of the DX-ICD system (atrial signal detection via a floating dipole integrated in the ICD lead) for remotely monitoring atrial high-rate episodes (AHRE) and their duration

Prof. Michael Haude, BIOMAG-I Coordinating Clinical Investigator, presented the latest results of the BIOMAG-I clinical study at the Cardiovascular Research Technologies (CRT) meeting. 1 At six months the angiographic and clinical data showed a low in-scaffold late lumen loss (LLL) rate and a good safety profile with no scaffold thrombosis. A low proportion of mal-apposed struts after implantation was observed, at six months struts were no longer discernable. The intravascular imaging documented a preservation of the scaffold area with a low mean neointimal area. Bioresorbable scaffolds have

BIOTRONIK announced today that it has received CE approval for the Selectra 3D implant tools to include left bundle branch area pacing (LBBAP) in addition to His-bundle pacing (HBP). Commonly referred to as conduction system pacing (CSP) these two approaches have emerged as a physiologic pacing alternative to avoid dyssynchronous contraction of the heart which can induce various negative long-term effects for patients. 1-3 Approved in 2021 for HBP, Selectra 3D’s safety and effectiveness for CSP has been shown in over 10 studies with more than 1,000 patients. In the multi-center Belgium

BIOTRONIK announces the FDA 510(k) clearance and CE mark of its Oscar ® ( One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter. Physicians in the U.S. have already used the novel device in more than 70 cases. As indicated per Instructions for Use, Oscar is intended for percutaneous transluminal interventions in the peripheral vasculature. The device was developed to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The Oscar peripheral multifunctional catheter is comprised of three user-adjustable components: The

The discovery of a high-severity vulnerability known as Log4Shell was disclosed publicly on December 9, 2021, while a related lower-severity vulnerability was disclosed on December 14, 2021. These vulnerabilities are present in a software library used by many servers worldwide (see Background for details). In light of this recent discovery, BIOTRONIK has carefully analyzed all of its provided services. The analysis concluded that the conditions for exploitation of the Log4Shell vulnerability and the related CVE-2021-45046 and CVE-2021-45105 vulnerabilities do not exist in any of BIOTRONIK’s

The most recent series of Apple iPhones include a stronger magnetic array than previous models. A recent study 1 published in the HeartRhythm Journal reported that therapy was suspended when an iPhone 12 was brought into close contact with specific implanted cardioverter defibrillator (ICD) devices. After further investigation, BIOTRONIK has concluded that there is no additional risk and our advice concerning potential interference from this and former iPhone models remains unchanged. We continue to advise patients implanted with BIOTRONIK cardiac devices to maintain the recommended distance

CardioMessenger devices form an essential part of BIOTRONIK’s remote monitoring system, enabling the secure transmission of critical patient and device data to the treating physician. As the company that pioneered remote monitoring, we have taken cybersecurity design seriously since 2001. It is integrated into our quality management system, all relevant business processes and prioritized at every step of the product life cycle. Our cardiac implants do not accept programming modifications or commands via any form of long-distance communication. By design, it is technically impossible to

As the COVID-19 pandemic continues, we are conscious of the enormous strain that you are all under. We share your concerns about the spread of the virus and the disruption it is causing globally. We are doing what we can to help minimize this disruption and to provide support so that you can focus on the critical task of saving lives. To this end, we would like to inform you of the following:

The US Food and Drug Administration has issued a Safety Communication regarding a family of cybersecurity vulnerabilities known as SweynTooth, which may introduce risks for certain medical devices that use Bluetooth Low Energy (BLE) wireless communication technology. If exploited, these vulnerabilities can allow unauthorized users to potentially cause a device to stop working, stop it from working correctly and/or bypass security to access certain device functions. The FDA has said it is not aware of any confirmed adverse events related to these vulnerabilities although software to exploit